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MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The long MIS (18 & 20 mm) implants can be used in a tilted manner.

MIS short implants are to be used only with straight abutments.

M4 short implants are indicated for delayed loading only.

Device Description

The MIS internal hex implant system includes two implant families: M4 and SEVEN. The subject implants system are endosseous dental implants and Endosseous dental implant abutments, manufactured from titanium TI-6Al-4V ELI. The implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. The root-shaped, screw-type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. The two implant families have the same internal hex connection and differ in regards to external geometry. Accordingly, the implants are used with the same abutments.

The implants are self-tapping, root-form with tapered threads and their surface is sand blasted and acid etched. The implants are supplied sterilized by gamma irradiation.

MIS M4 implants are cylindrical and conical shaped, self-tapping, have a V shaped thread design with three spiral channels and a flat, cutting tapered apex.

The MIS M4 Implants are available in the following diameters, platforms and lengths:

Narrow platform: 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16 mm
Standard platform: 3. 75 mm diameter: 8mm, 10mm, 16mm, 16mm, 18mm, 18mm and 20mm
. Standard platform: 4.2 mm diameter: 6mm, 8mm, 10mm, 16mm, 16mm, 18mm and 20mm
Wide platform: 5.0 mm diameter: 6mm, 8mm, 11.5mm, 13mm and 16mm
. Wide platform: 6.0 mm diameter: 6mm, 8mm, 10mm, 11.5mm, 13mm

MIS SEVEN implants are conical shaped with a domed apex. Their geometric design includes dual threads, three spiral channels stemming from the apex for self-tapping, micro rings on the implant neck, and a changing thread thickness along the implants are color coded for platform identification. The MIS SEVEN Implants are available in the following diameters, platforms and lengths:

Narrow platform (yellow): 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16 mm
Standard platform (purple): 3. 75mm diameter: 8mm, 10mm, 16mm, 16mm, 18mm and 20mm
Standard platform (purple): 4.2mm diameter: 8mm, 13mm, 16mm, 16mm, 18mm and 20mm
Wide platform (green): 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
. Wide platform(green): 6.0 mm diameter: 8mm, 10mm, 11.5mm, 13mm
The implants are designed for both two-stage procedures, with one internal thread for screwed abutment.

The MIS Internal Hex Dental Implant System is a two-piece device to be used in combination with a wide range of abutments provided in order to aid in the prosthetic rehabilitation.

Components:
The MIS Internal Hex Dental Implant System is to be used in combination with variety of the internal hex abutments (cover screws, healing caps, cement- retained abutments, gold abutments, OT-Equators & ball attachments, Multi unit abutments and Temporary Ti and Peek Abutments), including up to 300 angulated abutments.

Cover screws and healing caps are premanufactured prosthetic components directly connected to the endosseous dental implants and are indicated as temporary components to allow healing of the soft tissue. They are made of TI 6AL 4V ELI, and supplied sterile to the user, for single use.

Cement- Retained Abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant by a prosthetic screw, which is supplied with the abutments. Cement retained abutments are available straight or angulated, in different heights and diameters to accommodate the patients specific needs. They are available in 0, 10 or 20 degrees angulation in narrow platform, 0, 15 or 25 degrees angulation in standard platform and 0 or 15 degrees angulation for wide platform. They are made of TI 6AL 4V ELI, and supplied non sterile, to be steam sterilized by the user according to the labeling, intended for single use.

CPK abutments are premanufactured abutments directly connected to the endosseous dental implant by a prosthetic screw, which is supplied with the abutments. They are cement retained abutments intended to be used in temporary and permanent prosthetic rehabilitation. CPK abutments indicated for 0 degree angulation for straight implantation only. They are sold either on their own, or with additional components for impression taking and prosthetic fabrication. The abutments and prosthetic screw are made of TI 6AL 4V ELI. Their additional components intended for impression taking and casting are made of POM. Plastic healing caps intended to cover the CPK abutment until final restoration placement are made of PEEK. They are supplied non sterilized by the user according to the labeling, and intended for single use.

Gold Plastic abutments are pre-manufactured prosthetic abutments directly connected to the endosseous dental implant intended for permanent restoration, for either single or multiple tooth screw retained restorations. The lower part of the abutment which connects directly to the implant is made of gold AU, and the upper part is made of plastic (POM). The plastic part is burned out for casting with precious metals.. The abutment is connected to the implant by a prosthetic screw, supplied with the abutment, and made of TI 6AL 4V ELI. Gold abutments are straight abutments intended for 0 degree angulation for straight implantation only. The abutments are supplied non sterilized by the user according to the labeling, and intended for single use.

Multi-Unit abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant. They are intended for use in a completely edentulous jaw when screw retained prosthetis is preferred, for anchoring a fixed overdenture. Multi-units are available in 0 degrees for narrow platform, and in 0, 17 or 30 degrees for standard and wide platforms. The straight multi units' lower part is threaded and tightened directly to the implant, while the angulated multi-unit is connected to the implant by a prosthetic screw, supplied with the multi-unit and made of TI 6AL 4V ELI. The overdenture is connected to the multiunit by a screw. All multi units are made of TI 6AL 4V ELI. They are supplied sterile and intended for single use.

OT-Equators & Ball Attachments are premanufactured dental implant abutments directly connected to the endosseous dental implant by their lower threaded part, and are mostly used in completely edentulous jaws to connect to an overdenture bar to allow its insertion and removal. Ball attachments have a higher profile and ball shaped head, while the OT equators have a lower profile and a truncated head. Ball attachments are available straight for narrow and wide platforms, and in 0, 15 or 25 degrees for standard platform. OT Equators are available straight only. Both are made from TI 6AL 4V ELI, feature a Titanium Nitride (TiN) coating and are supplied with small-scale metal housing and replaceable nylon caps, offering various retention levels. The abutments are supplied non sterilized by the user according to the labeling and intended for single use.

Temporary abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant, intended for use as an aid in temporary prosthetic rehabilitation. They are straight abutments. They are available in TI 6AL 4V ELI and in natural PEEK. Both are attached to the implant by a prosthetic screw made from TI 6AL 4V ELI, supplied with the abutments, and are intended to be used for up to 6 months, and then replaced by permanent abutments. The post height is adjusted by the doctor to the appropriate height according to the intended restoration, as directed in the instructions for use supplied with the abutments are supplied non sterile, to be steam sterilized by the user according to the labeling and intended for single use.

There are two types of emergence profiles among the abutments, concave or straight emergence profile.

AI/ML Overview

This document is a 510(k) Summary for the MIS Internal Hex Dental Implant System. It describes the device, its intended use, and how it demonstrates substantial equivalence to legally marketed predicate devices through non-clinical performance data.

Here's the breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document focuses on demonstrating substantial equivalence to predicate devices rather than listing specific acceptance criteria with quantifiable metrics for each device performance aspect. Instead, it states that the device's performance is "at least equivalent" to the predicates. The primary performance metric mentioned is fatigue testing.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Meet biocompatibility standards.	Not explicitly tested for the subject device; deemed equivalent to predicate K040807 due to identical manufacturing, materials, facility, and intended use.
Fatigue Strength (per ISO 14801:2016): Withstand required cyclic loading without failure.	Worst-case implants and abutments withstood 5,000,000 cycles without failure at a "substantially equivalent load to the cited predicates." The test on standard platform worst-case implant-abutment assembly supports wide platform implants.
Sterility Assurance Level (SAL): Achieve SAL of 10⁻⁶ for sterile products (ISO 11137-1, -2).	Achieved SAL of 10⁻⁶ for gamma-irradiated products (implants, cover screws, healing caps, etc.).
Steam Sterilization Validation: Validate steam sterilization parameters for non-sterile products (ANSI/AAMI/ISO 17665-1, -2).	Validated for two methods: gravity displacement and pre-vacuum steam sterilization.
Endotoxin Limit: Meet endotoxin limits (USP 85, 161, ANSI/AAMI/ST72).	LAL test conducted periodically to verify endotoxin limit is within acceptance criteria for sterile products.
Disinfection Efficacy: Achieve at least 10⁶ reduction of microbiological challenge for non-sterile products (ANSI/AAMI/ISO 11737-1, AAMI TIR 30, AAMI TIR 12).	Disinfection procedure validated by demonstrating a reduction of at least 10⁶ of the microbiological challenge.
Shelf Life: Maintain integrity for a specified shelf life (ISO 11607-1).	Successfully supported a 5-year shelf life for sterilized products.
Risk Acceptability: All risks associated with the device are acceptable and as low as reasonably possible (ISO 14971).	Risk analysis conducted, and all risks were determined to be acceptable and as low as reasonably possible.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for the non-clinical tests (e.g., number of implants/abutments tested for fatigue). It mentions "worst case implants and abutments chosen for the tests" but no specific numbers.

Sample Size: Not specified (implied to be sufficient for engineering testing validation).
Data Provenance: The tests were conducted by MIS Implants Technologies Ltd. (Israel) or an "independent testing laboratory" for shelf life. No country of origin is explicitly stated for each test, but the submitter is based in Israel and the US Agent in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable. The study involves non-clinical engineering and laboratory testing (mechanical, sterilization, biocompatibility, shelf-life, risk analysis) of a dental implant system, not a diagnostic or AI-driven device requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the same reasons as point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC or human-in-the-loop study was conducted. This device is a dental implant system, not an AI or diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. This device is a physical dental implant system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests conducted, the "ground truth" refers to established engineering and regulatory standards:

Fatigue: ISO 14801:2016 standard.
Sterilization: ANSI/AAMI/ISO 11137-1, -2; ANSI/AAMI/ISO 17665-1, -2.
Endotoxin: USP 85, USP 161, ANSI/AAMI/ ST72.
Disinfection: ANSI/AAMI/ISO 11737-1:2006 (R)2011, AAMI TIR 30:2011 and AAMI TIR 12:2010.
Shelf Life: ISO 11607-1.
Risk Analysis: ISO 14971.

8. The sample size for the training set

This section is not applicable. There is no training set as no AI/machine learning component is involved.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

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